OECD TG 498
For this test 3D human reconstructed skin models are incubated with three to five concentrations of the test material diluted in sesame oil / or water. One set of models is exposed to UVA radiation, another set is kept in the dark (without irradiation) for the same period. After exposure all models are rinsed and incubated over night. At the next day, vitality is assessed by MTT-test (colorimetric assay). If the difference between irradiated and not irradiated models is less than 30 % the test material has no phototoxic potential.
|Mean tissue viability difference
+UVA compared to -UVA
|in vivo Prediction|
|> 30 %||phototoxic|
|< 30 %||non-phototoxic|
Prediction of phototoxicity is supported if, in addition, the (+UVA) induced reduction in tissue viability shows a dose response relationship.